(93 days)
Not Found
No
The 510(k) summary describes a plasma calibrator and control plasma, which are reagents used in coagulation factor assays. There is no mention of AI or ML in the intended use, device description, or any other section. The device is a biological reagent, not a software or hardware system that would typically incorporate AI/ML.
No
This device is a calibrator and control plasma used for in-vitro diagnostic assays, not for direct therapeutic intervention on a patient.
No
The device is described as a calibrator and control plasma for existing assays, meaning it is used to ensure the accuracy and reliability of diagnostic tests, not to directly diagnose a condition itself.
No
The device description clearly states it is composed of lyophilized human plasma, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Biophen Plasma Calibrator and Biophen Normal and Abnormal Control Plasma are used "in the assay for the coagulation factors Antithrombin III and Protein C" and "as quality control of some coagulation factors." These are tests performed in vitro (outside the body) on biological samples (plasma) to provide information about a patient's health status (coagulation factors).
- Device Description: The device is described as "citrated normal human plasma, lyophilised" and used as a "reagent" and "quality control." These are typical components and uses of IVD devices.
- Predicate Devices: The listed predicate devices (K001256 Plasma Control N and K020878 Lyphochek® Hemostasis Control) are also IVD devices used for similar purposes in hemostasis testing. This further supports the classification of this device as an IVD.
The information provided aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in Biophen Plasma Calibrator coagulation factors Antithrombin III and Protein C.
The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors.
The Biophen Normal and Abnormal Control Plasma are tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation.
This control plasma is also tested for the absence of Activated Protein C resistance (APCR) and found to be normal: when a normal plasma (as the Normal control plasma) is tested with or without Activated Protein C (APC), the ratio obtained (APTT + APC/APTT) is >= 2.00 for the Normal Control Plasma.
Product codes
GGN
Device Description
BIOPHEN Plasma Calibrator reagent is composed of citrated normal human plasma, BIOPHEN Plasma Calibrator leagent is compose of each it contains 12 vials lyophilised in the presence of additives and presentives unter lyophillsed in the presente of adultived with 1 ml distilled water. of lyophilised reagent to be reconstituted with 1 ml distilled water.
Matrix Base: Stabilized reagent from human plasma
Form: Lyophilized
Volume: 1ml per vial
Composition: Normal human citrated pooled plasma: Freeze dried powder containing human plasma >75% Hepes
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Summary Report For Biophen Plasma Calibrator
Description:
BIOPHEN Plasma Calibrator reagent is composed of citrated normal human plasma, BIOPHEN Plasma Calibrator leagent is compose of each it contains 12 vials
lyophilised in the presence of additives and presentives unter lyophillsed in the presente of adultived with 1 ml distilled water.
of lyophilised reagent to be reconstituted with 1 ml distilled water.
Proprietary Name: Biophen Plasma Calibrator
Established Name: Plasma Calibrator
Intended use:
The Biophen plasma calibrator is used as a calibrator in the assay for the The Blophen plasma Calibrator is used as a callerator in the accorporation III & Protein C. It can be also used as normal human plasma control.
The following table shows various parameters, which are measured using the assays The lollowing table shows various paramoters, while waskage inserts:
| Assays | Reagents | Manufacturers | Reference |
|---|---|---|---|
| ATIII | Biophen | Hyphen Biomed | 221102 |
| Antithrombin | 221105 | ||
| Protein C | Biophen Protein | ||
| C | Hyphen Biomed | 221202 | |
| 221205 | |||
| Lupus | DWtest® | American | 810 |
| Anticoagulant | DWconfirm® | Diagnostica | 815/815L |
DWtest, DWconfirm are registered trade marks from American Diagnostica Inc.
The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.
Matrix Base: Stabilized reagent from human plasma
Form: Lyophilized
Volume: 1ml per vial
Composition:
Normal human citrated pooled plasma: Freeze dried powder containing human plasma >75% Hepes